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510(k) K153547

ECHELON Oval V 5.1 MRI System by Hitachi Medical Systems America, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2016
Date Received
December 11, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Hitachi Medical Systems America, Inc.

  • K163528 — HITACHI Supria Whole-body X-ray CT System Phase 3 (March 3, 2017)
  • K162079 — TRILLIUM Oval Head Coil 32 (September 16, 2016)
  • K161748 — SUPRIA w/guideShot Option (August 17, 2016)
  • K160152 — Trillium Oval V 5.1 MRI System (May 20, 2016)
  • K150595 — SCENARIA Phase 3 Whole-body X-ray CT System (October 30, 2015)
  • K150565 — Supria Whole-body X-ray CT System (September 30, 2015)
  • K151015 — ECHELON Oval V 5.0 MRI System (July 29, 2015)
  • K143537 — Sirius Starmobile tiara (March 6, 2015)
  • K142734 — TRILLIUM Oval MR System (March 2, 2015)
  • K123509 — SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM (March 29, 2013)

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